Quality assurance in laboratories

1. Quality assurance in laboratories Quality Control May 2007

2. Learning objectives • At the end of the presentation, participants should • Understand the principles of Quality control • Understand the importance for internal and external quality control schemes

3. Quality is.... • invisible whenGOOD • impossible to ignore whenBAD

4. Quality ? • = sum-total of all the characteristics of a product/service that has a bearing upon the utilization of the product/service to the entire satisfaction of the consumer

5. Quality ? • Consistency • Accuracy • Precision • Right result • First time • Every time

6. Objectives of quality in lab • Support provision of high quality health-care • Reduce morbidity • Reduce mortality • Reduce economic loss • Ensure credibility of lab • Generate confidence in lab results

7. Consequences of poor quality • Inappropriate action • Over-investigation • Over-treatment • Mistreatment • Inappropriate inaction • Lack of investigation • No treatment • Delayed action • Loss of credibility of laboratory • Legal action

8. Quality assurance = Internal quality control + External quality assessment Continuously and concurrently assessing lab work Retrospectif and periodic

9. Assessment of Quality System Audit, On-site inspection Internal External Accreditation Man-driven Material-driven • Quality Assessment • Internal • External • Schematic way: External Quality Assessment Scheme (EQAS)

10. 1 - Internal quality control in laboratory • = set of procedures undertaken by the staff to ensure quality of reports • Total process beginning with sample collection up to final reporting

11. Quality in labs is mutual responsibility of….. • Laboratory specialists • Clinicians • Public health physicians

12. Factors influencing internal quality Sample Transport Sample handling Sample receiving Sample Collection Analysis Patient preparation Outside laboratory Within laboratory Requisition Results Patient Reports Doctor

13. 1.1 - Factors influencing quality: Pre-analytical Right Investigation Ex: blood culture in the first week of enteric fever and not Widal Specimen Ex: No stool in SARS Collection technique Ex: Stool from bedpan→ collect stool in a clean container Storage and transportation Ex: Not kept in cold chain- overgrowth of other bacteria Quantity Ex: Not enough serum for serology Labeling Ex: Mismatch of sample Laboratory Ex: Not necessary test capacity

14. 1.2 - Factors influencing quality: Analytical PROFICIENCY OF PERSONNEL: Education, Training, Aptitude, Competence, Commitment, Adequate number, CME, Supervision, Motivation EQUIPMENT RELIABILITY: Meet technical needs, Compatible, User & maintenance friendly, Cost effective, Validated REAGENTS STABILITY, INTEGRITY AND EFFICIENCY: Stable, Efficient, Desired quality, Continuously available, Validated SPECIFICITY & SENSITIVITY OF SELECTED TEST: Adequate ST, Sufficient SP, cost effective, compatible with, available infrastructure and expertise, interpretable, meets the needs/ objectives, validated • USE OF APPROPRIATE CONTROLS: • Internal: Labs, Calibrated against national • External: Supplied by manufacturer, National, International ANALYTICAL FACTORS Procedural reliability using Standard Operating Procedures DOCUMENTATION: All the written policies, plans, procedures, instructions and records, quality control procedures and recorded test results involved in providing a service or the manufacture of a product Assessment

15. Documentation • If you have not documented it, • you have NOT done it … • If you have not documented, • it is a RUMOUR !!!

16. Value of Documentation • Ensures processes and outcomes are traceable • Processes can be audited, thus external assessments can take place • Tool for training • Reminds you what to do next

17. Standard Operating Procedures (SOP) • = comprehensively written document that describes the laboratory procedure and all other related issues • Essential for ensuring uniformity in laboratory procedures SOP for Gram Staining

18. Validation • = is about determining whether something does what it is supposed to do

19. Importance of validation • Validation - before you introduce something • Re-validation • after you have changed/modified • periodic • Validation is applied to: • SOP • reagents • equipment • software

20. 1.3 - Factors influencing quality: Post-analytical • Right recording and reporting • Right interpretation • Range of normal values • Right turnaround time • Report to right user

21. Reporting • Unequivocal message • Numerical value with units as and when required KISS ! (Keep it short and simple)

22. Bottom-line • Quality costs , • but poor quality costs more … € €

23. Training • The quality system is only as good as the staff who actually work with it • No matter how good the quality system is on paper, quality cannot be achieved if the theory cannot be translated into practice • Training policy and plan • Training must include an understanding of why quality is important • Training should be need based, for all staff and reviewed

24. 2 - External Quality Assessment • 3 types, mainly 2: • An EQA organizer provides surveys in which identical material will be tested by all participating laboratories •  ex: WHO/NHLS programme in Africa • Participating laboratories send specimens to EQA organizer for Rechecking •  ex: Tuberculosis bacilloscopy quality control in Morocco • On-site visits with physical assessment)

25. EQA • According to the ISO definition,EQA (also known as ‘proficiency testing’ (PT) or ‘EQ Control = EQC’) refers to: • a system of objectively checking laboratory results by means of an external agency • including comparison of a laboratory's result at intervals with those of other laboratories • the main objective being the establishment of trueness

26. What makes microbiology different to other EQA schemes? • Microbiology samples are fundamentally non-uniform. • Microbiological taxonomy is fundamentally imprecise. • Microbiological samples are changing. • Traditional microbiological analysis depends upon behavior, not constitution. • Microbiology has many “right” answers.

27. Objectives of EQA schemes for laboratories • Laboratory oriented objectives: • 1. Identifying possible deficiencies in laboratory practice, and guiding participants in any corrective actions to be taken for improvement; • 2. Identifying the reliability characteristics of particular methods, materials and equipment under routine conditions and suggest corrective actions as appropriate; • 3. Assessing and monitoring the impact of training; help for the preparation of future trainings

28. Objectives of EQA schemes for laboratories • Public health oriented objectives: • 4. Providing the basis for the comparability of results during epidemiological surveillance and disease control • 5. Collecting information on laboratory measurements ( intra- and inter-laboratory) to alert professionals and/or government bodies about problems related to traceability and harmonization of results, and establish limits of acceptability of results as appropriate for a given purpose; • 6. Collecting information for the purpose of licensing or accreditation of laboratories;

29. 2.1 Example of EQA organizer:CMPT, Canada

30. 2-2 Rechecking (RC) • Participating laboratories send specimen to be rechecked on a regular basis to the EQA body • Targeted specimens and/or randomized specimens • Usually blind, can be single or multiple • Example of tuberculosis bacilloscopy in Morocco: • 180 centres in the country • All positives smears (targeted) • 10% of all negative smears (randomized)

31. 2.3 On-site visits • Laboratory assessment • Laboratory licensing and/or accreditation • Combined with the other types of EQA • After repeated problems (corrective action) • During on-site supervision (routine checking) • After training session (practical implementation of the training ) •  In addition to the assessment of the existing conditions, QC material can also be provided (slides, strain, sera, specimen for rapid tests …)

32. The ideal situation: 2 types togetherand very targeted on-site visits • On-site visits: • Expensive, heavy • Only for one laboratory • Very much time consuming • Very effective if motivated staff • Very complementary to all other schemes especially rechecking • On-site visits should be used with « extreme » situations • « Initial » situation: laboratory assessment, licensing • « Bad » situation: repeated problems, failures in training • « Good » situation: accreditation

33. 3- Accreditation • = process of inspection of laboratories and their licensing by a third party to ensure conformity to pre-defined criteria • Very very long task (As example, around 20% of French laboratories are accredited by COFRAC, it takes around 2-3 years to follow the roadmap) • Last step of the entire process • Quality assurance (procedures, way of working) • IQC • EQC • Networking of the laboratories • … and then only accreditation if 1-4 completed

34. Carry home messages…….. • Quality assurance measures what a lab can do to improve reliability • As an epidemiologist, you may engage the laboratory in a dialogue andtactfully ask about QA measures in place • BE CAREFUL ! An epidemiologist is NOT in a position to assess the reliability of the lab or to evaluate its QA procedures as this requires a specific expertise

35. To summarize • The determinants that ensure the quality of the laboratory & therefore the specimen results are:

36. Quality Control Developed by:The Department of Epidemic and Pandemic Alert and Response of the World Health Organization with the assistance of:European Program for Field Epidemiology Training Canadian Field Epidemiology Programme Thailand Ministry of Health Institut Pasteur